Dianben 850 mg
Dianben 850 mg
50 tabletsActive substance: metformin
Applications of Dianben 850 mg film-coated tablets
• The drug belongs to a group of drugs for the treatment of non-insulin-dependent diabetes (type 2 diabetes mellitus) in adults and children aged 10 years.• The product is a medicine used to reduce high blood sugar in patients with diabetes (type 2 diabetes); particularly in overweight patients in whom no adequate control of blood glucose levels has been achieved solely through diet and exercise.
o adults
Your doctor may prescribe alone (monotherapy) or in combination with other oral anti-diabetic medicines or insulin, the drug.
o Children and adolescents
children ages 10 and adolescents, the doctor can prescribe the drug alone (monotherapy) or in combination with insulin.
• For overweight adult patients with diabetes (diabetes mellitus type 2) could after diet failure reduced incidence of diabetic complications treatment be detected with metformin as first-line therapy.
Absolute contraindications of Dianben 850 mg film-coated tablets
• Medicines should not be taken
o if you are allergic to metformin hydrochloride or any of the excipients;
o if you suffer from acidification of the blood in diabetes (diabetic ketoacidosis), a preliminary stage of coma;
o if you have liver problems or kidney problems (glomerular filtration rate below 45 ml / min);
o if you suffer from acute conditions that can lead to impaired renal function, eg. B.
fluid loss through persistent vomiting or severe diarrhea,
if you have a severe infection, such as an infection of the lungs, bronchi or the kidney. Severe infections may lead to kidney problems, which you are at risk to develop an acidification with lactic acid (lactic acidosis).
circulatory collapse (shock),
studies with administration of iodinated contrast agents in the blood vessels, before, during and until 48 hours after the examination;
o if you suffer from acute or chronic disease which may lead to a lack of oxygen in the body tissues:
if you are being treated for heart failure or have had a heart attack recently, severe circulatory problems (such. As a shock) or difficulty breathing have. This could lead to a lack of oxygen in the tissue, whereby you are at risk to develop an acidification with lactic acid (lactic acidosis).
o if you have poor liver function, acute alcohol intoxication, alcoholism;
o if you are breastfeeding.
• Be sure to ask your doctor for advice,
o if you are breastfeeding.
o if you have to undergo an X-ray or other imaging study in which you an iodine-containing contrast medium is injected.
patients notice
• Warnings and Precautions
o Please talk to your doctor or pharmacist before taking this medicine.
o The risk of an undesirable accumulation, and thus the risk of acidification of the blood with lactic acid (lactic acidosis) is mainly determined by renal function, which is why a secured normal kidney function is a precondition for a therapy with this preparation.
o The assessment of your kidney function, based on the determination of your serum creatinine level is, therefore, be repeated at least at yearly intervals, possibly even earlier. If your serum creatinine is at the upper limit of normal, allow at least two to four times a year to carry out the inspection. It is important to note that in the elderly, serum creatinine is meaningful especially alone is not always; optionally is then a different value for the assessment of renal function, the creatinine clearance to determine before starting treatment.
o Particular caution should be exercised in situations where there may be a renal impairment with you (z. B. to initiating therapy with certain drugs used to treat high blood pressure or a rheumatic disease).
o Please note the following risk of lactic acidosis in particular.
o The risk of an undesirable accumulation, and thus the risk of acidification of the blood with lactic acid (lactic acidosis) is mainly determined by renal function, which is why a secured normal kidney function is a precondition for a therapy with this preparation.
o The assessment of your kidney function, based on the determination of your serum creatinine level is, therefore, be repeated at least at yearly intervals, possibly even earlier. If your serum creatinine is at the upper limit of normal, allow at least two to four times a year to carry out the inspection. It is important to note that in the elderly, serum creatinine is meaningful especially alone is not always; optionally is then a different value for the assessment of renal function, the creatinine clearance to determine before starting treatment.
o Particular caution should be exercised in situations where there may be a renal impairment with you (z. B. to initiating therapy with certain drugs used to treat high blood pressure or a rheumatic disease).
o Please note the following risk of lactic acidosis in particular.
The drug may, particularly in patients with impaired renal function, cause a very rare but very serious complication that is characterized is designated by an acidification of the blood with lactic acid and a lactic acidosis. The risk of developing lactic acidosis, is even with poorly controlled diabetes, prolonged fasting or alcohol consumption, dehydration (dehydration) due to severe diarrhea or vomiting, liver problems and with any medical situation where a body region with too little oxygen is supplied (as in acute, severe heart disease), increased.
It is important that you regularly take your medication, follow the diet instructions and do your sports program, as this may reduce the risk of lactic acidosis.
The onset of lactic acidosis can be insidious and the symptoms can be nonspecific, such as Vomiting, abdominal pain with muscle cramps, disturbed general condition with severe fatigue and difficulty breathing. Other symptoms include decreased body temperature and decreased heartbeat. If you get these symptoms, seek immediate medical attention, as lactic acidosis may lead to coma. Immediately stop taking the drug and contact a doctor or the nearest hospital emergency department.
It is important that you regularly take your medication, follow the diet instructions and do your sports program, as this may reduce the risk of lactic acidosis.
The onset of lactic acidosis can be insidious and the symptoms can be nonspecific, such as Vomiting, abdominal pain with muscle cramps, disturbed general condition with severe fatigue and difficulty breathing. Other symptoms include decreased body temperature and decreased heartbeat. If you get these symptoms, seek immediate medical attention, as lactic acidosis may lead to coma. Immediately stop taking the drug and contact a doctor or the nearest hospital emergency department.
o Even with abnormal liver function extreme caution.
o In studies with administration of iodinated contrast agents in the blood vessels is a risk of acute renal failure. Your therapy with the drug must therefore be discontinued before carrying out the investigation and should not be resumed until 2 days after the examination, if previously established by a recent study that the renal function is normal.
o If an operation is performed under general anesthesia or spinal anesthesia planned for you, the treatment should be discontinued 2 days in advance. You must at least 2 days after the procedure be continued or after resumption of food and if it is ensured that your kidney function is normal.
o Tell your doctor if you suffer from a bacterial or viral infection (for example influenza, respiratory infection, urinary tract infection).
o Continue in the therapy with the drug your diet and pay special attention to a uniform distribution of carbohydrate intake during the day. If you are overweight, you should continue your reduction diet under medical supervision.
o The supply of large quantities of alcohol represents a risk for the occurrence of hypoglycemia and lactic acidosis, so you should avoid alcohol during therapy with metformin.
o In studies with administration of iodinated contrast agents in the blood vessels is a risk of acute renal failure. Your therapy with the drug must therefore be discontinued before carrying out the investigation and should not be resumed until 2 days after the examination, if previously established by a recent study that the renal function is normal.
o If an operation is performed under general anesthesia or spinal anesthesia planned for you, the treatment should be discontinued 2 days in advance. You must at least 2 days after the procedure be continued or after resumption of food and if it is ensured that your kidney function is normal.
o Tell your doctor if you suffer from a bacterial or viral infection (for example influenza, respiratory infection, urinary tract infection).
o Continue in the therapy with the drug your diet and pay special attention to a uniform distribution of carbohydrate intake during the day. If you are overweight, you should continue your reduction diet under medical supervision.
o The supply of large quantities of alcohol represents a risk for the occurrence of hypoglycemia and lactic acidosis, so you should avoid alcohol during therapy with metformin.
• Children and adolescents
o Prior to treatment in children and adolescents, the doctor must (type 2 diabetes mellitus) have secured the diagnosis of diabetes.
o During one-year controlled clinical trials, no effect on growth and puberty through metformin was observed, however, are no long-term results on this front.
o Because few children of age group were trapped between 10 to 12 years in the clinical trials, be especially careful when children in this age group are treated.
o During one-year controlled clinical trials, no effect on growth and puberty through metformin was observed, however, are no long-term results on this front.
o Because few children of age group were trapped between 10 to 12 years in the clinical trials, be especially careful when children in this age group are treated.
• Older people
o Due to the often limited in the elderly renal function dosage after renal function should be determined. Let regularly for this reason measurements of kidney function values perform at the doctor.
• Special warnings
o metformin in an undesirable (accumulating) trigger or promote the emergence of acidification of the blood with lactic acid (lactic acidosis), a complication that - can assume life-threatening proportions (eg coma.) - if it is not treated early. Causes an acidification with lactic acid can be next to overdose, disregard the existence or occurrence of contraindications. Therefore, the contraindications are strictly observed.
o signs of incipient blood acidification with lactic acid can resemble the side effects of metformin on the gastrointestinal tract: nausea, vomiting, diarrhea and abdominal pain.
o The frame with muscle pain and cramps, excessive increase in the breathing and clouding of consciousness with coma can develop within hours and requires immediate Urgent treatment in a hospital.
o signs of incipient blood acidification with lactic acid can resemble the side effects of metformin on the gastrointestinal tract: nausea, vomiting, diarrhea and abdominal pain.
o The frame with muscle pain and cramps, excessive increase in the breathing and clouding of consciousness with coma can develop within hours and requires immediate Urgent treatment in a hospital.
• Driving and using machines
o A sole therapy with this drug will not cause blood sugar (hypoglycaemia) and therefore has no impact on driving performance or the ability to operate machinery. In a combination treatment with sulfonylureas, insulin or other medications with hypoglycemic effect your ability to drive and use machines or to work in potentially hazardous activities may be affected by possible hypoglycemia.
pregnancy Note
• If you are pregnant or breastfeeding, or if you suspect you may be pregnant or intend to become pregnant, ask before taking this medicine your doctor or pharmacist for advice.• Pregnancy:
o Patients with diabetes who are pregnant or want to be, this should not be treated with the drug.
o Blood sugar levels should be set in these cases with insulin at normal levels. Tell your doctor so that he can change the treatment on insulin accordingly.
• Lactation
o Blood sugar levels should be set in these cases with insulin at normal levels. Tell your doctor so that he can change the treatment on insulin accordingly.
o This drug should not take while breastfeeding.
Dosage of 850 mg film-coated tablets Dianben
• Take the medicine exactly as a doctor has told you. You should check with your doctor or pharmacist if you are unsure.• The dosage must be determined for each patient specifically by the physician based on the blood glucose levels and monitored by regular medical check.
• For the individual adjustment to the required maintenance dose and film-coated tablets containing 500 mg and 1000 mg of active ingredient metformin hydrochloride are available.
• If the doctor prescribes otherwise, the usual dose is:
o dosing instructions for adults
The usual dose 2 to 3 tablets per day initially (equivalent to 1700 mg to 2550 mg metformin hydrochloride), taken during or after meals.
The maximum daily dose is 3 tablets per day (equivalent to 2550 mg metformin hydrochloride).
o use in children and adolescents
dosage instructions for children under 10 years and adolescents
monotherapy and combination therapy with insulin:
The usual dosage is one tablet per day initially (equivalent to 850 mg metformin), taken during or after the meal.
The dose (equivalent to 2 g of metformin hydrochloride) can be increased to a maximum recommended daily dose of 4 tablets of 500 mg or 2 tablets with 1000 mg.
o In patients with renal impairment where GFR between 45 and 60 ml / min, the initial dose is 500 mg or 850 mg metformin hydrochloride once daily. The maximum dose is 1000 mg daily, divided into 2 doses. Renal function should be closely monitored (every 3 - 6 months).
• Please talk to your doctor or pharmacist if you have the impression that the effect is too strong or too weak.• If you take more than you should
o If you take more than you should, it can lead to acidification of the blood with lactic acid coming (lactic acidosis). Symptoms of lactic acidosis are nonspecific, such. As vomiting, abdominal pain with muscle cramps, a general feeling of malaise with severe fatigue and difficulty breathing. Other symptoms include decreased body temperature and decreased heartbeat. If you get these symptoms, seek immediate medical attention, as lactic acidosis may lead to coma.
Immediately stop taking this drug and contact a doctor or the nearest hospital emergency department.
Immediately stop taking this drug and contact a doctor or the nearest hospital emergency department.
• If you forget to take
o If you forget to take, take the next administration time a the prescribed dose and try in the future to comply with the Regulation.
Do not take a double dose if you have forgotten dose.
Do not take a double dose if you have forgotten dose.
• If you stop taking
o Do not stop treatment without medical prescription from, you have to expect that the blood sugar level rises uncontrollably and long-term sequelae of diabetes, such. as eye, kidney or vascular damage occur.
• If you have further questions on the use of this product, ask your doctor or pharmacist.
side effects
• Like all medicines, have this side effects, although not everybody gets them.• Possible side effects
o gastrointestinal complaints
Very common (may affect more than 1 in 10 people)
nausea, vomiting and diarrhea, abdominal pain, loss of appetite. These occur most frequently during initiation of therapy and resolve spontaneously in most cases. To prevent these problems, it is recommended to take the drug with or after meals in the form of 2 or 3 divided doses. If these symptoms persist for longer, stop taking the drug and talk to your doctor.
Common (may affect up to 1 in 10 people)
changes in taste
o Metabolism and nutrition disorders
Very rare (may affect up to 1 10 000 patients treated)
acidification of the blood with lactic acid (lactic acidosis). It is a very rare but serious complication, particularly in patients with impaired renal function. Symptoms of lactic acidosis are nonspecific, such. As vomiting, abdominal pain with muscle cramps, disturbed general condition with severe fatigue and difficulty breathing. Other symptoms include decreased body temperature and decreased heartbeat. If you get these symptoms, seek immediate medical attention, as lactic acidosis may lead to coma. Immediately stop taking the drug and contact a doctor or the nearest hospital emergency department.
decrease of vitamin B12 absorption and consequent reduction of the serum levels. This should be considered in patients with a particular form of anemia (megaloblastic anemia) as a possible cause.
o disorders of the skin and skin appendages
Very rare (may affect up to 1 10 000 patients treated)
skin reactions such as redness, itching and hives
o Hepatobiliary disorders
Very rare (may affect up to 1 10 000 patients treated)
abnormalities in liver function tests or liver inflammation (hepatitis) with or without jaundice that disappear after discontinuation.
o blood disorders:
not known (from the available data can not be estimated)
Isolated cases of reversible enhanced degradation or decomposition of red blood cells (hemolytic anemia) have been reported.
o Vascular disorders:
A case of an inflammatory vascular disease (leukocytoclastic vasculitis) and the particular form of pneumonia (pneumonitis) have been reported.
• Children and young people are currently limited data on side effects. These show comparable frequency, type and severity of side effects as in adults.• If you notice any side effects, contact your doctor or pharmacist. This includes any possible side effects that are not specified.
interactions
When multiple drugs are used concomitantly, there may be interactions. Effects and side effects of drugs may be altered. Whether an interaction occurs, depends on various factors.therefore Always speak with your doctor or pharmacist to determine whether an interaction you actually plays a role. Doctor or pharmacist Only assess your individual risk factors for interaction. If necessary to devise appropriate measures doctor or pharmacist. Put the doctor prescribed medicines without talking with your doctor or pharmacist from.
There are known interactions between "Dianben 850 mg film-coated tablets" and other drugs. If you still are taking other medicines, ask your pharmacist to clarify whether it can possibly be interactions with "Dianben 850 mg film-coated tablets".
Storing
Store. Medicines out of reach of childrenDisposal
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